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Methods and systems for scoring extracellular matrix biomarkers in tumor samples

A biomarker and tumor technology, applied in the preparation of test samples, biochemical equipment and methods, sampling, etc., can solve the problems of complex evaluation, inconsistency, and inability to reproduce stained tissue samples

Inactive Publication Date: 2019-07-30
VENTANA MEDICAL SYST INC
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Problems solved by technology

[0011] Quantitative scoring methods are mainly done through photomicrography and digital image analysis, which makes the evaluation of HA more complicated
Although pathologists annotate stained slides, it is difficult to rely on computerized systems to distinguish non-tumor-associated HA expression from tumor-associated HA expression (see Tool, 2009, Clin Cancer Res 15:7492-7468; Provenzano et al., 2012 , Cancer Cell 21:418–429; Lokeshwar et al., 2005, Cancer Res. 65:7782–7789; Kultti et al., 2014, Biomed Res Int. Article ID 817613; see also US Patent No. 8,846,034; US Patent Application No. 2014 / 0348817)
Demonstrate that those methods are not only inconsistent with clinical outcome data, but also not reproducible by routine slide examination of stained tissue samples by pathologists

Method used

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  • Methods and systems for scoring extracellular matrix biomarkers in tumor samples
  • Methods and systems for scoring extracellular matrix biomarkers in tumor samples
  • Methods and systems for scoring extracellular matrix biomarkers in tumor samples

Examples

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Embodiment 1

[0140] Example 1 describes testing of the scoring assay of the present disclosure.

[0141] During testing of the scoring method of the present disclosure, multiple samples from cell lines and xenografts (PC3, BxPC3 and DU145), normal human tissues as well as tumor tissue samples such as PDA, breast cancer, non-small cell lung cancer (NSCLC) and gastric cancer were used. tissue samples. Samples were stained on the VENTANA BenchMark automated slide staining system using TSG6-rabbit Fc fusion protein (TSG6-Fclb) as a biomarker-specific reagent and the VENTANA OptiView DAB IHC Detection Kit. Affinity histochemistry assay was used to select patients with pancreatic ductal adenocarcinoma (PDA) containing hyaluronan (HA) who could benefit from PEGPH20 adjuvant therapy using a cutoff between high and low HA 50% staining of tumor-associated ECM at any HA intensity above background.

[0142] Figure 4A Examples of samples scored using the methods of the present disclosure are shown....

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Abstract

Methods and systems for scoring hyaluronan-stained tissue samples by assessing the area of tumor-associated extracellular matrix (ECM) with hyaluronan staining compared to the entire surface area of the relevant portion of the sample. The methods and systems of the present disclosure may be used to, for example, to select patients for receipt of specific treatments.

Description

[0001] Cross References to Related Applications [0002] This application hereby claims the benefit of United States Provisional Patent Application No. US 62 / 398,787, filed September 23, 2016, the contents of which are hereby incorporated by reference in their entirety. [0003] field of invention [0004] The present invention relates to methods and systems for scoring extracellular matrix (ECM) biomarkers (such as hyaluronan) in tissue samples, and their role in diagnosing and / or prognosing disease and / or predicting disease. use in response to therapy. [0005] Background of the invention [0006] Many ECM components have been implicated in disease pathogenesis. See Jarvelainen et al., Pharmacol Rev., Vol. 61, Issue 2, pp.198-223 (2009). An example is hyaluronan (HA). HA is of interest due to its diverse roles in ovulation, embryonic development, wound healing, and inflammatory diseases (Meyer and Palmer, 1934, J Biol Chem 107:629-34; Dicker et al., 2014, Acta Biomater 10...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/574
CPCG16H10/20G16H10/40G01N33/574G16H50/30C12N9/2428C12Y302/01036G01N1/30G01N2001/302G06T7/0012
Inventor S.克利法J.濮
Owner VENTANA MEDICAL SYST INC
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